Recall Z-0986-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes, Inc.
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
| Date | Feb 16, 2014 (initiated Jan 27, 2014) |
| Status | Terminated |
| Reason | Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. |
| Root cause | Labeling Change Control |
| Action | A recall notification letter, dated January 27, 2013, was sent to End Users and sales consultants. |
| Quantity | 1,132,096 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.